Study design, materials and methods
Study design, materials and methods: The study design was a two-tailed, longitudinal, qualitative case study (1) carried out in parallel to a randomised controlled trial (2). The ‘tails’ were the biofeedback PFMT group and PFMT alone group. Following ethical approval, purposive maximum variation sampling (based on difference in treatment centre, UI type, and therapist type) was used to invite a subsample of women, who had consented to the trial, to take part in the case study. Interested women were sent written information about, and asked to consent to, the case study specifically. The data from each recruited women formed one case. Women were interviewed at baseline, six, 12 and 24 months after randomisation. Interviews were semi-structured, digitally recorded and transcribed. Where possible, baseline and six month interviews were face to face and either at the participant’s home or in the clinic, and 12 and 24 month interviews were by telephone. Interviews explored women’s experiences of the social contexts within which they experienced UI, the intervention they received, adherence and outcome. Data analysis principally followed case study analytic traditions (1) whereby all data from a case were analysed and findings collected together to form a case summary with a focus on understanding a woman’s experience of UI, intervention, adherence and outcome and how these factors interacted. Case summaries within a ‘tail’ were collated, the cases compared, and the two tails were then compared to one another.
Sample: Forty women, 20 per group, were recruited as planned; 24 had data at all four time points (10 biofeedback PFMT and 14 PFMT alone), with 2856 minutes of interview data recorded. There was a wide age range in both groups (20 to 76 years). Eleven women had stress UI and 29 Mixed UI with similar proportions in the groups. Six women were treated in community clinics, 16 in University hospitals and 18 in District General Hospitals with similar proportions in the groups. Most women were treated by specialist women’s health physiotherapists (n=36) and four by continence nurses.
Adherence: Adherence varied considerably between individual women. There were examples of women who had good adherence throughout the two-year follow up, those who adhered to some extent, and those who did not adhere well at any point (Table 1). Patterns of adherence to PFMT were similar between the biofeedback PFMT and PFMT alone groups. Intervention adherence varied over time as a result of multiple contextual factors. Most women maintained belief in their ability (self-efficacy) to restart PFMT exercise after a break; for instance:
“I don’t feel like I need to go back and see a doctor or, you know, see a nurse or anything, I feel like if it got bad again I could, you know, I've got these exercises to fall back on” [Case 27, 24 month interview, biofeedback PFMT group].
Outcome: As with adherence there was considerable variation in UI symptom outcome at the 24 month follow up (Table 2). There were women who were ‘cured’ or ‘almost cured’; those with some improvement; and those with no improvement or / worsening symptoms.
Context: Contextual factors influenced adherence in many ways. Key facilitators of adherence were: a desire to improve, and prevent deterioration of, UI symptoms and the influence of the treating therapist. For instance:
“that's what I'm hoping…to stop the leaking, maybe be able to go back to yoga and not feel like I'm worrying about leaking or whatever” [Case 27, baseline interview, biofeedback PFMT group]
“[therapist name] is, is a very good therapist, that made a big difference” [Case 36, six month interview, PFMT alone group].
Key barriers to adherence were: (lack of) time in the context of women’s busy lives and life taking over. For instance:
“I haven't really had an awful lot of time to concentrate of exercises and stuff like that, just because we've been so busy … our business is still just really extremely, extremely busy” [Case 15, 24 month interview, PFMT alone group].
Interpretation of results
Interpretation of results: There is an interaction between the context within which women live their lives, their desire and ability to maintain longer-term PFMT adherence (with or without biofeedback) and their UI outcomes. Women greatly value the input of therapists, and face difficult personal choices about life priorities, balancing these with PFMT adherence and UI outcome. For clinicians, recognition of, and shared decision-making that includes, consideration of this complexity is necessary along with specific attention to problem solving and action planning for relapse management.